Home

The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; these include providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The aim of the programme is to provide patients and healthcare professionals with timely access to important breakthrough medical devices by accelerating their development, assessment and review, while preserving the statutory standards for premarket approval and 510(k) clearance.

Thoraflex Hybrid is a single use medical device combining a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft and is indicated for the surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta.

Advanced age, smoking or genetic inheritance may result in the aortic wall weakening and bulging which can lead to a ruptured thoracic aortic aneurysm (TAA). TAA rupture remains a significantly fatal condition with most patients only surviving for six hours if there is no surgical intervention.

Another condition is aortic dissection where a tear develops in the vessel wall; should either occur the artery may rupture and only one in five patients survives.

Joseph Coselli (professor, vice chair and chief, Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, USA) the principal investigator for Thoraflex Hybrid commented: “This breakthrough designation from the FDA will allow US physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single stage procedure instead of the conventional treatment involving two procedures thus lowering the risk of patient mortality and potentially reducing overall operating time and hospital costs.”

John Canning, chief technical officer with Terumo Aortic added: “The announcement from the FDA is very encouraging and we look forward to close collaboration with the FDA to advance treatment options for patients suffering from this deadly disease.”

Thoraflex Hybrid is the latest innovation within Terumo Aortic’s portfolio of surgical, endovascular, and hybrid devices to treat every segment of the aorta. Thoraflex Hybrid became the world’s first multi-branched “frozen elephant trunk” prosthesis when it received CE Mark approval in 2012.

Source VascularNews

Duc Tin Clinic

Chia sẽ qua facebook bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua google bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua twitter bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua MySpace bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua LinkedIn bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua stumbleupon bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua icio bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua digg bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Chia sẽ qua yahoo bài: Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Tin tức liên quan

Vesteck completes first-in-human use of several Suture-Tight devices

Age is just a number: Individual patient data meta-analysis probes safety of CEA in the elderly

Artificial intelligence can predict risk of complications after endovascular aneurysm repair

Bluegrass Vascular announces Journal of Vascular Surgery paper reporting use of Surfacer system

Vascular access creation: EndoAVF keeps future options open, but is not a replacement for surgical fistulas

SUPPORT CONSULTANT

Make an Appointment

I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

I sincerely thank you !. Tel: 0938303275

Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.